Effects of Fast Bar on Physiological Fasting

Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and longevity continues to grow. While benefits of intermittent fasting have been convincingly demonstrated in rodent models, the more limited data in humans is less clear.

The short-term fasting (e.g. 12 to 48 hours in duration) utilized in many intermittent fasting programs are considered safe, but some individuals may find them subjectively difficult. As such, the question of whether the benefits of fasting can be obtained while small amounts of food are consumed is of substantial interest.

One commercially available product that is designed to be consumed during periods of intermittent fasting is the Fast Bar™,which stems out of the well-researched fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Bar™ is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting state. This may allow for extension of a fasting period through reduced subjective difficulty of fasting.The objective of this study is to evaluate the metabolic and subjective effects of consuming a novel food product (Fast Bar™) after a short period of fasting.

• Dinner (Other): Study subjects will consume a standardized ready-to-eat meal as dinner.
• Fasting (Other): Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.
• Study food (Other): Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).

Primary outcomes

• Ketone Area Under the Curve [BHB Area Under the Curve between 0 to 4 hours after consuming the study foods]: Blood ketone (ß-hydroxybutyrate, BHB) area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.
• Glucose Area Under the Curve [Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods]: Blood glucose area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Ability and willingness to provide written informed consent;
* Ability and willingness to use Zoom teleconference;
* Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
* BMI 20-35 kg/m2 (inclusive) at screening;
* In good health (as determined by medical history to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days).

Exclusion Criteria:

* Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation* (*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);
* History of gastric bypass (based on medical history provided at screening);
* Under medications aimed at keeping blood glucose under control (based on medical history provided at screening);
* Type 1 diabetes (based on medical history provided at screening);
* Taking insulin, insulin analogs, or octreotide (based on medical history provided at screening);
* Food allergies which would make the subject unable to consume the food provided (based on medical history and information provided at screening) (participants will be asked to review the ingredient lists for the dinner meal, the breakfast and the Fast Bar, and to state that they are not allergic to the ingredients to the best of their knowledge);
* Women who are pregnant;
* Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men) (based on medical history and information provided at screening).

Participant flow

Outcome results

• Ketone Area Under the Curve (Primary), Mean, mg/dL*h: Fast Group 1.27 +/- 0.53; Breakfast Group 0.62 +/- 0.18; Fast Bar Group 1.17 +/- 0.34
• Glucose Area Under the Curve (Primary), Mean, mg/dL*h: Fast Group 365 +/- 50; Breakfast Group 401.4 +/- 42.3; Fast Bar Group 363.5 +/- 37.3

Adverse events

Time frame: 2 days.

• Study Protocol and Statistical Analysis Plan (PDF, 2020-06-19)
• Informed Consent Form (PDF, 2020-07-13)

• William C Hsu, MD, Principal investigator, L-Nutra Inc